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Wednesday, December 5, 2012

Are Flu Shots A Scam?

It is flu season again, and we are bombarded with both public service and commercial announcements urging us to get vaccinated. More often than not, these exhortations are coming from pharmacies. It is common to see special billboards, full display window posters, and other signs in front of an in pharmacies offering special deals on flu shots (“Get a flu shot here and get 10 percent off on any item in the store’). While accounting for only 20 percent of the total flu shots given, this proportion is increasing rapidly – approximately 7 percent per year (Business Weekly 11.27.12).

Flu shots have become big business. According to Business Weekly, approximately 50 percent of American over 2 years of age get flu shots, and the average cost last year was $25. That equals nearly $3.7 billion a year. Much of that is pure profit for pharmacies:

Why are pharmacists doing this? Flu shots are a moneymaker. “The climate for retail pharmacies is not good right now,” Esterbrook said. “The reimbursement on (drug) prescriptions is low. It’s a tough business.” He said pharmacists are paid according to the cost of the medication; they are not paid for their technical skills and knowledge, or for any counseling they give customers. When they fill prescriptions, they often lose money or make a $1.50 dispensing fee.

“When we give flu shots, that’s a service with a fee, and we’re considered a health care provider of a service,” he said. While he did not reveal the revenues he receives from administering vaccines, he said it is profitable.

“Definitely worthwhile,” was how he put it. (Business Weekly)

Twenty-five dollars, most of it covered by insurance, would seem like a good deal if the vaccinations actually worked. Yet the data are not convincing. Their greatest ‘effectiveness’ is in the young and healthy and the worst is in the aged and infirm. Recent research suggests that it is not the flu shot that is giving young people protection, it is their healthy and vigorous immune system.

Shannon Brownlee and Jeanne Lenzer have written (Atlantic 11.09 Does The Vaccine Matter?) what is considered one of the most thorough reviews of the literature concerning the efficacy of the influenza vaccine. The vaccine, she concludes, does not work that well at all; reports of its efficacy have been overstated and based on faulty research:

Unfortunately, the very people who most need protection from the flu also have immune systems that are least likely to respond to vaccine. Studies show that young, healthy people mount a glorious immune response to seasonal flu vaccine, and their response reduces their chances of getting the flu and may lessen the severity of symptoms if they do get it. But they aren’t the people who die from seasonal flu. By contrast, the elderly, particularly those over age70, don’t have a good immune response to vaccine—and they’re the ones who account for most flu deaths.

Even the CDC on its website backs off from giving any statistics on efficacy of the vaccine:

How well the flu vaccine works (or its ability to prevent influenza illness) can range widely from season to season and also can vary depending on who is being vaccinated. At least two factors play an important role in determining the likelihood that influenza vaccine will protect a person from influenza illness: 1) characteristics of the person being vaccinated (such as their age and health), and 2) the similarity or "match" between the influenza viruses in the vaccine and those spreading in the community. During years when the viruses in the vaccine and circulating viruses are not well matched, it’s possible that no benefit from vaccination may be observed.

Other researchers have been less cautious:

Yet while other flu researchers may not like what Jefferson has to say, they cannot ignore the fact that he [Cochrane Collaboration’s Thomas Jefferson]. knows the flu-vaccine literature better than anyone else on the planet. He leads an international team of researchers who have combed through hundreds of flu-vaccine studies. The vast majority of the studies were deeply flawed, says “Rubbish is not a scientific term, but I think it’s the term that applies.” (Brownlee)

In a recent review of data reported in The Lancet (10.26.11, Osterholm et al) concluded that the overall protection rate for the entire population 17-65 was approximately 60 percent. However, researchers concluded that there were no reliable data on age groups younger than 17 and especially older than 65 – the population most highly susceptible to disease.

In 1989, only 15 percent of people over age 65 in the U.S. and Canada were vaccinated against flu. Today, more than 65 percent are immunized. Yet death rates among the elderly during flu season have increased rather than decreased (Brownlee)

Given the fact that data are very difficult to collect concerning the incidence of flu (most people who get the disease suffer only mild symptoms and don’t even know they have it; and those who get a more severe case go to bed until it’s over and never seek medical attention), the CDC reports on mortality, and has touted the fact that the flu vaccine decreases mortality by 50 percent. Many researchers have dismissed this claim.

In 2004, Jackson [Senior Researcher, Group Health Research Center] and three colleagues set out to determine whether the mortality difference between the vaccinated and the unvaccinated might be caused by a phenomenon known as the “healthy user effect.” They hypothesized that on average, people who get vaccinated are simply healthier than those who don’t, and thus less liable to die over the short term. People who don’t get vaccinated may be bedridden or otherwise too sick to go get a shot. They may also be more likely to succumb to flu or any other illness, because they are generally older and sicker. (Brownlee)

In other words the mortality rate in young people is expected to be extremely low, regardless of infection; and the mortality rate in the elderly is expected to be high. Add to that the fact that the flu shot does not have much effect in older people because of its weak stimulating effect on the immune system, the picture presented by the CDC is distorted indeed.

Why, then, has the federal government stockpiled millions of doses of antivirals, at a cost of several billion dollars? And why are physicians being encouraged to hand out prescriptions to large numbers of people, without sound evidence that the drugs will help?

The short answer may be that public-health officials feel they must offer something, and these drugs are the only possible remedies at hand. “I have to agree with the critics the antiviral question is not cut-and-dried,” says Fauci (NIH). “But [these drugs are] the best we have.” The CDC’s Nancy Cox also acknowledges that the science is not as sound as she might like, but the government still recommends their use. (Brownlee)

A more nuanced answer might be the following:

“Vaccines give us a false sense of security,” says Sumit Majumdar [Biotechnologist,Senior Staff Research, Becton Dickenson]. “When you have a strategy that [everybody thinks] reduces death by 50 percent, it’s pretty hard to invest resources to come up with better remedies.” (Brownlee)

Research continues, although slowly, to find a universal flu vaccine – i.e. one that will protect against all influenza, regardless of the strain. Currently new vaccines have to be formulated every year well in advance of the flu season, and are based on predictions, probability, and best estimates. This probabilistic approach results in good years (higher vaccine efficacy) and bad years. A universal vaccine would take the guesswork out of the equation. Good conspiracy theory says that there is no real interest in neutering a $4 billion flu vaccine industry; but of course this is only speculation.

Perhaps the best reason why people continue to get flu shots even when the probability of protection is low, is “Why not?”. Insurance co-pays are low, side effects minimal, and there is always a CVS within a few minutes walk. I am in one of those groups cited above for whom the protection rates are very low, and yet I got a shot this year like I did last year and the year before. Next year is another story.

6 comments:

All technology is oversold in the U.S.; it would be strange if the flu shot were any different (see your own non-critical acceptance of a "universal" vaccine without pausing to ask about drawbacks). Modest protection, for modest cost. Seems like an OK deal to me.

> I am in one of those groups cited above for whom the protection rates are very low

As you probably know, getting vaccinated is not all about you, you, you -- it's about community. I sat next to someone at dinner whose infant niece was in an ICU because of the flu (too young to be immunized, of course). I was glad I had done what I could to reduce the odds, however modestly, that I had contributed to that horrible event.

As you weigh the apparently disturbing cost of your next ~$15 (CDC price list) flu shot, I hope you'll consider whether you have any direct or indirect contact with the more helpless members of your community: infants, AIDS sufferers, chemo patients, etc. Perhaps a modest increase in their odds of living is worth it?

But you assume that if you get the vaccine, you will protect those fragile individuals. There is no reason to expect that, particularly when in protecting, maybe, against 5-15% of the influenza viral load with the vaccine, you are told that you will be 'protecting yourself and your loved one against the flu'...thereby inadvertantly and ignorantly exposing yourself and your loved ones to the OTHER 80-95% of the circulating influenza-like illness viruses. Hospitals actually allow vaccinated staff members to go unmasked around susceptible patients because they have been vaccinated. Curiously, the unvaccinated are required to wear masks, which will probably do more to protect patients from ALL airborne infectious agents.

Read Dr. Tom Jefferson's commentaries. He is the Reviewer, Cochrane Acute Respiratory Infections Group and Cochrane Vaccines Field. His commentary is readily available online and highly insightful on this particular issue.